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510(k) Data Aggregation

    K Number
    K214015
    Device Name
    Palm NRG cellulite body device (model: Palm NRG body device)
    Manufacturer
    Heat In A Click LLC.
    Date Cleared
    2022-09-26

    (278 days)

    Product Code
    PBX, GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Heat In A Click LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Palm NRG cellulite body device (model: Palm NRG body device) is intended for delivering non thermal RF combined with massage for temporary reduction in the appearance of cellulite.
    Device Description
    Palm NRG cellulite body device (model: Palm NRG body device) is a portable, non-invasive, at home skin care device. It works for with radio frequency (RF) to help users to enjoy the care skin. The device is a noninvasive, non-ablative device and it is supplied as non-sterile, it has 2 buttons, one for power on/off, the other one for level adjust. The main unit is equipped with accessories of an adapter and a charging base. The charging base is used to connect the adapter and the main unit.
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    K Number
    K191938
    Device Name
    FitRelief TENS&EMS Wireless Device
    Manufacturer
    Heat In A Click LLC.
    Date Cleared
    2020-08-28

    (406 days)

    Product Code
    NGX, NUH
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Heat In A Click LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
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